Atorvastatin for primary intracerebral hemorrhage

Statins for Treatment Of Primary IntraCerebral Hemorrhage (STOP ICH)

This trial will see if adding atorvastatin to usual care helps adults (18–80) who have a spontaneous intracerebral hemorrhage and are treated within 3–24 hours of symptom onset.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 264 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The Second Hospital of Anhui Medical University (Academic / other)
• Locations: 22 sites (Anqing, Anhui and 21 other locations)
• Trial ID: NCT07088250 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, randomized, open-label, blinded end-point (PROBE) trial will randomize 264 adults with spontaneous supratentorial intracerebral hemorrhage to best medical treatment (BMT) alone or BMT plus atorvastatin 20 mg once daily for 21 days in a 1:1 ratio. Eligible patients present within 3–24 hours of symptom onset, have a baseline hematoma volume of 5–35 mL and GCS ≥9, and atorvastatin can be started within 48 hours. The primary efficacy endpoint is the proportion of patients with poor functional outcome at 90 days (modified Rankin Scale 4–6), with safety and adverse events monitored throughout follow-up. The trial uses blinded endpoint assessment to limit bias while delivering open-label therapy.

Who should consider this trial

Good fit: Adults aged 18–80 with spontaneous supratentorial ICH confirmed by CT, baseline hematoma volume 5–35 mL, GCS ≥9, who can be enrolled within 3–24 hours and start atorvastatin within 48 hours are ideal candidates.

Not a fit: Patients with secondary causes of ICH (trauma, tumor, aneurysm, AVM, venous thrombosis, hemorrhagic transformation), anticoagulant-related ICH, immediate surgical needs, pre-stroke mRS >1, pregnancy, or active liver disease are excluded and unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding atorvastatin could lower the chance of severe disability or death at 90 days after intracerebral hemorrhage.

How similar studies have performed: Observational studies and small randomized trials on statin use after ICH have shown mixed results, and large randomized evidence demonstrating clear benefit is currently lacking.

Eligibility criteria

Inclusion Criteria:

* Patients with a diagnosis of spontaneous intracerebral hemorrhage (ICH) confirmed by computed tomography (CT);
* Age 18-80 years;
* Hematoma located in the supratentorial region;
* Time from symptom onset or last known well to baseline CT ranging from 3 to 24 hours;
* Atorvastatin treatment can be initiated within 48 hours of symptom onset or last known well;
* Glasgow Coma Scale (GCS) score ≥9;
* Baseline hematoma volume of 5-35 mL;
* Signed informed consent obtained.

Exclusion Criteria:

* ICH secondary to trauma, tumor, aneurysm, arteriovenous malformation (AVM), vascular anomaly, hemorrhagic transformation of infarction, cerebral venous thrombosis, or anticoagulant-related ICH;
* Patients who have undergone or are scheduled for immediate surgical intervention;
* Pregnancy or lactation;
* Use of oral anticoagulants within 1 month prior to symptom onset;
* Pre-stroke mRS \>1;
* Known allergy to statins, active liver disease, liver dysfunction, or rhabdomyolysis;
* Known terminal illness with a pre-stroke life expectancy of less than three months, or patients with planned withdrawal of care.

Where this trial is running

Anqing, Anhui and 21 other locations

• Anqing First People's Hospital of Anhui Province — Anqing, Anhui, China (Recruiting)
• Fuyang City Sixth People's Hospital — Fuyang, Anhui, China (Recruiting)
• Fuyang Hospital of Anhui Medical University — Fuyang, Anhui, China (Recruiting)
• Fuyang People's Hospital — Fuyang, Anhui, China (Recruiting)
• Hefei Eighth People's Hospital — Hefei, Anhui, China (Recruiting)
• Hefei First People's Hospital — Hefei, Anhui, China (Recruiting)
• The Second Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
• Huainan Xinhua Hospital — Huainan, Anhui, China (Recruiting)
• The First Affiliated Hospital of Anhui University of Science and Technology (Huainan First People's Hospital) — Huainan, Anhui, China (Recruiting)
• Huoqiu First People's Hospital — Lu'an, Anhui, China (Recruiting)
• Shucheng People's Hospital — Lu'an, Anhui, China (Recruiting)
• Si County People's Hospital — Suzhou, Anhui, China (Recruiting)
• The First Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• Kaifeng Central Hospital — Kaifeng, Henan, China (Recruiting)
• Xihua County People's Hospital — Zhoukou, Henan, China (Recruiting)
• Xiangyang Hospital of Traditional Chinese Medicine — Xiangyang, Hubei, China (Recruiting)
• The First People's Hospital of Chenzhou — Chenzhou, Hunan, China (Recruiting)
• Yancheng First People's Hospital — Yancheng, Jiangsu, China (Recruiting)
• Chengdu Western Hospital — Chengdu, Sichuan, China (Recruiting)
• Panzhihua Central Hospital — Panzhihua, Sichuan, China (Recruiting)
• Dazhu County People's Hospital — Dazhou, Sizhuan, China (Recruiting)
• The Third Affiliated Hospital of Chong Qing Medical University — Chongqing, China (Recruiting)

Study contacts

• Study coordinator: Qi Li

Conditions Cerebrovascular Disorders; Intracranial Hemorrhages; Intracranial Hemorrhage; Intracerebral Haemorrhage; Intracerebral hemorrhage; Treatment; Atorvastatin; Outcome